EUGENE, OR, United States
EUGENE, OR, United States

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Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 648.79K | Year: 2016

DESCRIPTION provided by applicant Epilepsy is a debilitating brain disorder and surgery is the key treatment modality for those patients whose seizures cannot be controlled medically Epilepsy surgery is complex requiring multimodal imaging data for planning and execution and image analysis software is essential for this process The overall goal of this application is to develop a robust commercial software platform for multimodal image analysis for epilepsy surgery that can obtain regulatory approval for clinical use in both academic and non academic hospitals These software tools were developed in part for the needs of our epilepsy research at Yale over the last years under NIH NIBIB funding and in part internally at Electrical Geodesics Inc for the brain segmentation source analysis and display parts of the forthcoming GeoSource software package The innovation in this proposal lies i the development of innovative image analysis methodology that addresses specific needs in epilepsy image analysis and ii the translation of tested research software to a new design that will enable its successful transition via regulatory approval to clinical use The significance of this proposal is that it aims to provide clinically usable epilepsy surgical planning software with explicit support for multimodal image integration and intracranial electrode localization that can be integrated with the image guided navigation systems used for neurosurgery This tool would have a major impact on both surgical planning and image guided epilepsy neurosurgery PUBLIC HEALTH RELEVANCE In the US the lifetime cost of epilepsy for an estimated people with an onset in is projected at $ B and the annual cost for an estimated million prevalent cases is estimated at $ B In many of these cases the treatment procedure requires identifying the abnormal brain region involved and removing it via neurosurgery Epilepsy surgery costs over $ per case and since the surgery is complex and often involves two phases image analysis software is critical to integrate multimodal imaging and EEG recording for pre and intra operative decision support


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 499.37K | Year: 2016

DESCRIPTION provided by applicant Epilepsy is a debilitating brain disorder and surgery is the key treatment modality for those patients whose seizures cannot be controlled medically Epilepsy surgery is complex requiring multimodal imaging data for planning and execution and image analysis software is essential for this process The overall goal of this application is to develop a robust commercial software platform for multimodal image analysis for epilepsy surgery that can obtain regulatory approval for clinical use in both academic and non academic hospitals These software tools were developed in part for the needs of our epilepsy research at Yale over the last years under NIH NIBIB funding and in part internally at Electrical Geodesics Inc for the brain segmentation source analysis and display parts of the forthcoming GeoSource software package The innovation in this proposal lies i the development of innovative image analysis methodology that addresses specific needs in epilepsy image analysis and ii the translation of tested research software to a new design that will enable its successful transition via regulatory approval to clinical use The significance of this proposal is that it aims to provide clinically usable epilepsy surgical planning software with explicit support for multimodal image integration and intracranial electrode localization that can be integrated with the image guided navigation systems used for neurosurgery This tool would have a major impact on both surgical planning and image guided epilepsy neurosurgery PUBLIC HEALTH RELEVANCE In the US the lifetime cost of epilepsy for an estimated people with an onset in is projected at $ B and the annual cost for an estimated million prevalent cases is estimated at $ B In many of these cases the treatment procedure requires identifying the abnormal brain region involved and removing it via neurosurgery Epilepsy surgery costs over $ per case and since the surgery is complex and often involves two phases image analysis software is critical to integrate multimodal imaging and EEG recording for pre and intra operative decision support


Patent
Electrical Geodesics, Inc. | Date: 2013-04-16

Methods for use of EIT. Disclosed are: (1) EIT used to obtain a final solution to an EIT inverse problem for localizing tissues undergoing changes in impedance, which is used as a constraint on solving an EEG source localization inverse problem; (2) EIT used with MREIT, where the MREIT is used to constrain the solutions to the EIT inverse problem for the distribution of static tissue impedance; (3) EIT used with MREIT, where the MREIT is used to constrain the solutions to the EIT inverse problem for localizing tissues undergoing changes in impedance; and (4) EIT according to any of (1)-(3) as feedback for modifying at least one of the location, magnitude, and timing of currents injected for the purpose of neurostimulation.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.75M | Year: 2014

DESCRIPTION provided by applicant The goal of this SBIR project is to design a low profile high resistive MR compatible dense array EEG dEEG sensor net for simultaneous dEEG fMRI recordings in fields as high as Tesla This novel sensor net the andquot InkNetandquot will provide safe noninvasive and affordable dEEG fMRI technology to both clinicians and researchers thereby enabling routine multimodal imaging of human brain function with unprecedented spatiotemporal resolution Application of this technology will enhance basic science of healthy brain function as well as treatment of many neural pathologies and pre surgical planning The InkNet will overcome current cross modal safety and artifact issues that have so far severely limited the effectiveness of simultaneous dEEG fMRI by leveraging expertise in innovative polymer thick film PTF technology at the A A Martinos Center Massachusetts General Hospital and dEEG sensor net design and technology expertise at Electrical Geodesics Inc EGI In Phase I we established feasibility with the development and testing of our first channel InkNet prototype using screen printed high resistive PTF ink leads interfaced with EGIandapos s patented geodesic net structure and MR compatible EEG acquisition hardware and software Phase II will build on the successes of our Phase I prototype while working to refine its design enhance production manufacturability and cost efficiency and conduct performance and safety tests Specific Aim is to study the latest innovations in flexible and stretchable substrates and conductive inks to improve conformability and electrode contact and reduce MR induced ballistocardiogram artifact Sample circuits using the best candidate materials will be printed in house and put to rigorous testing for optimal performance in high MR fields Specific Aim will refine the InkNet design including an electrode pedestal with an ultra low profile of d mm to fit in tight MR head coils and a novel lead layout enabled by state of the art inkjet printing of leads up to meters in length double sided mil trace width and te novel flexible materials Specific Aim will implement the new design and materials to produce Phase II channel InkNet prototypes using QA production and test procedures and new custom designed assembly and test fixtures to enhance speed and reliability Specific Aim will test and validate the Phase II prototype for human safety and data integrity Safety tests will be performed using finite difference time domain FDTD numerical simulations with an anatomically accurate head model followed by actual temperature measurements using a specially developed phantom CHEMA and high power TSE imaging sequences that induce RF heating After confirming safety MRI and EEG data integrity will be tested at T and T field strengths using clinically relevant structural scans and fMRI EEG resting visual and auditory protocols Data quality will be compared to data from EEG only and MRI only sessions and against data from a commercial MR compatible net built with traditional copper wire technology Our test plan will be reviewed with FDA and adjusted where required to meet requirements for a K predicate application PUBLIC HEALTH RELEVANCE The goal of this project is to develop a system for simultaneous measurement of brain activity using two complementary methods electroencephalography EEG and functional magnetic resonance imaging fMRI This state of the art system will offer brain scientists and clinicians a safe non invasive tool for studying human brain function with unprecedented spatial and temporal precision This knowledge will help us better understand healthy brain function treat many disorders e g epilepsy and improve pre surgical planning


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.68M | Year: 2014

DESCRIPTION provided by applicant While it is well known that the brain undergoes rapid developmental changes from birth to early childhood remarkably little is understood about the relationship between changes in brain size and composition and cognitive development Yet several potentially debilitating neurocognitive disorders are a consequence of delays or abnormalities in brain development and childhood epilepsy has been shown to be associated with an increased risk of learning disabilities attention deficit hyperactivity disorder and depression These associations make it imperative that we gain a better understanding of the relationship between cognitive and anatomical development In children the study of cognitive and brain developmental trajectories are best accomplished using non invasive techniques that are not overly restrictive of movement and do not require ionizing radiation Of available techniques electroencephalography EEG particularly with the advent of high density sensor arrays provides the ability to assess cognitive function safely and non invasively Our central goal is to develop age specific pediatric head models to improve current source localization imaging in pediatric populations under the hypothesis that functional localization of cognitively important brain regions and networks requires an accurate model of head tissue geometry and conductivity This Phase project will build on work accomplished in phase to create age clusters that differ significantly in measures of brain and skull development For each cluster we will build and test head models that are accurate both in morphological features and in regional differences in tissue conductivity which plays a critical role in the ability to accurately reconstuct brain network activity from EEG signals Once age specific average head models have been developed and tested we will validate their improved accuracy based on neurophysiological data using EEG and functional magnetic resonance imaging methods in children from infancy to young adulthood This project will result in the public release of a set of innovative age specific head models together with newly developed software from our project website www pedeheadmod net In addition the project will provide a novel commercial product Child Geosource R which will allow source localization studies without the otherwise limiting need for CT or MR scanning for accurate head models PUBLIC HEALTH RELEVANCE This project will result in commercialization of a novel product for use in non invasive neuroimaging in children This product Child Geosource R will create age group head models for children from infancy to young adulthood providing clinicians and researchers with a tool for optimal use of non invasive high density EEG in localizing seizure activity and elucidating the developmental trajectories of neural networks underlying cognitive function in normal children as well as those at risk for psychiatric disorders


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 670.85K | Year: 2012

DESCRIPTION (provided by applicant): Clinical neonatal monitoring is also vital for diagnosis and prognosis of acute pathologies. One such pathology, neonatal intraventricular hemorrhage (IVH), is a common consequence of premature birth, with approximately30 percent of infants weighing less than 1500 g having some degree of bleeding. While some neonates exhibit clear outward signs related to IVH such as apnea, pallor, seizures and metabolic acidosis, up to 50 percent of IVHs may be clinically silent. LargeIVHs are associated with unfavorable neurologic outcomes. Adverse neurodevelopmental sequelae include cerebral palsy, seizures, posthemorrhagic hydrocephalus (which may require a ventriculoperitoneal shunt), blindness, deafness, and cognitive impairment (Hintz and O'Shea 2008, Goldenberg and Jobe 2001). Although ultrasound is almost universally employed as a retrospective screen at 7 days of life, 50 percent of IVHs occur during the first day of life (and 75 percent in the first 3 days). Further ultrasoundis less sensitive to Grade II IVHs (Babcock et al 1982, Mack et al 1981), and its availability as a diagnostic tool is operator dependent, with limited hours of availability. The variation in clinical presentation and need to intervene early stresses theneed for a simple to interpret device that can monitor and detect developing IVHs in real time, allowing administration of supportive therapies (blood products) or treatments (activated factor VII). While the clinical consequences of IVH are severe, littleis known about its exact etiology. Many physiologic disturbances (e.g., loss of cerebral blood flow autoregulation, increased central venous pressure, hypotension) have been associated with IVHs through retrospective studies, but exact cause-effect relationships between these parameters do not exist (Ballabh 2010). Further, causal connections between the incidence of IVH and neuroelectric abnormalities observed in IVH such as positive rolandic sharps and seizures have not been established. In this projectwe propose developing a device that can be used in a future comprehensive investigation of the connections between circulatory and neuroelectric abnormalities in the context of IVH. If it is successful, this device may not only aid understanding of the underlying mechanisms leading to IVH, but also be of use in early identification of developing bleeds, and combined with appropriate therapies, limiting the extent of bleeding and other brain damage. Monitoring of premature infants poses unique challenges, one of these being the ideal of non-invasive bedside monitoring. We have previously developed an electrical imaging device that uses an EEG- like electrode array to continuously monitor and quantify small (lt 0.5 ml) blood accumulations in the neonatal ventricles. We propose developing a monitoring device that can simultaneously gather EEG and bleeding status data using the same electrode array, with minimal impact on clinical management. Data from the device will be made available in a manner that also allows comparison with other physiological monitoring systems. PUBLIC HEALTH RELEVANCE: Premature birth accounts for roughly 12 percent of all live births annually in the United States. Despite advances in technologies and treatments in the past decade, the incidence of severe acute complications for very premature infants accompanied by risks for chronic medical conditions, such as cerebral palsy, have not markedly diminished since the mid-1990s. A majority of these neurodevelomental problems are associated with damage to the subventricular zone and subsequent intraventricular hemorrhage. Currently, detection of intraventricular hemorrhage is retrospective. The overall goal of this project is to develop a novel brain-monitoring device that will allow the bedside clinician to improve the delivery of care to these neonates in real time, thereby decreasing the extent of intraventricular hemorrhages and decreasing the severity of neurodevelopmental deficits.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.00M | Year: 2012

DESCRIPTION (provided by applicant): The goal of this SBIR project is to design a cost-effective, lightweight, integrated, whole-head dense-array electroencephalography and near-infrared spectroscopy (dEEG/NIRS) brain imaging and data analysis system for non-invasive recording of brain activity in neonates and young children. This system will permit bedside monitoring of immediate at-risk neonates, and early identification and intervention for abnormalities that predict developmental disabilities and cognitive deficits. A dense array of 128 combined optoelectrodes sitting on the surface of the scalp will simultaneously record brain electrical activity (EEG), and cerebral blood oxygenation changes (NIRS), providing complementary measures of brain function. Having demonstrated feasibility in Phase I with a partial array and single modulated wavelength, the first Specific Aim in Phase II is to extend the approach to complete a commercially viable, whole-head and dual-wavelength dEEG/NIRS acquisition system for infants. The existing design will be modified to use dual-wavelength LED emitters for hemoglobin measurements, with enhanced stability and robustness of the integrated optoelectrodes. New architecture will modulate up to 64 NIR light sources (32 dual-wavelength LEDs) at different frequencies and demodulate signals from up to 96 detectors. NIRS data acquisition software will be refined and further improvements will be made to the integration and synchronization with other acquisition streams, including Net Station EEG, Polygraphic Input Box data (e.g., ECG, EMG), and E-Prime experimental control software. The second Specific Aim is to design commercial, advanced data analysis tools for accurate computation of blood oxygenation changes measured with integrateddEEG/NIRS sensors. This NIRS analysis software will complement EGI's existing EEG processing and source analysis software. The first step will be to implement standard computational tools (based on the modified Beer-Lambert equation) that are used to determine changes in oxy- and deoxy-hemoglobin as measured by recovered NIR signals. Then, the computational parameters will be refined through advanced anatomical infant head modeling, and numerical modeling of the path, scattering, and absorption properties of NIR light through infant head tissues. The third Specific Aim will test and validate the integrated dEEG/NIRS system hardware and software for data integrity, functionality, and usability. Simultaneous dEEG and NIR data will be collected with the complete 128-sensor system during resting state and functional tasks in 30 neonates. The functional data task wil present simple speech and matched non-speech sounds that have previously resulted in individual differences in brain electrical patterns predictive of later dyslxia diagnosis. Outputs from in-house NIRS analysis tools will be cross validated with existing open-source analysis tools (e.g., HomER). Usability of the acquisition and analysis software will be assessed and further refinements made. Finally,commercial user guides for hardware, acquisition software, and analysis software will be prepared to accompany the dEEG/NIRS acquisition and analysis product. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop the first lightweight device capable of providing real-time spatial and temporal brain imaging information regarding newborn and young infant neural functioning. Such a development would facilitate bedside monitoring of immediate at-risk newborns and offer us the incredible opportunity to identify in very young infants the structural and functional abnormalities that may contribute to later emerging developmental disabilities. Such early identification is vital to the development of early interventions that may mitigate or even preclude the emergence of the disorder.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 149.84K | Year: 2012

The purpose of the proposed work is to demonstrate the feasibility of a novel instrument for multi-channel nuclear Magnetic Resonance Imaging (MRI) at ultra-low field (ULF). The instrument will overcome issues involved with conventional MRI systems use in combat casualty care. It will also provide direct measurement of neurophysiological activation dynamics by magnetoencephalography (MEG) and will be compatible with other imaging modalities like dense array EEG and NIRS. The system will be focused on the assessment of Traumatic Brain Injury, an increasingly important class of combat casualty and source of morbidity. The instrument will be designed to satisfy a demanding slate of performance, system design, operational and siting requirements to facilitate transport and allow operation at Combat Support Hospitals. We propose to develop the first of a new generation of clinical and research systems, combining the technologies of MEG and MRI into a single instrument with revolutionary capabilities for imaging brain structure and function. We term this hybrid instrument neurological MRIneuMRI. Although this project focuses on military requirements, if successful the system is likely to have sweeping implications for scientific investigation and civilian medical practice.


Patent
Electrical Geodesics, Inc. | Date: 2012-07-25

A method and apparatus for locating tracts of electrical brain activity. A source localization procedure may be performed including solving the inverse problem subject to one or more constraints resulting from a tractographic procedure, and a tractographic procedure may be performed that includes obtaining a probabilistic assessment of tract connectivity that takes account of the results of a source localization procedure.


Patent
Electrical Geodesics, Inc. | Date: 2016-03-02

A method and system for controlling neural activity in the brain, including performing a source localization procedure and a neurostimulation procedure, and using the former as a monitor to provide for feedback control of the latter.

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